Cotrimoxazole 480mg tab
(i) ROUTE OF ADMINISTRATION
Oral
DOSAGE AND ADMINISTRATION
Contraindicated in paediatric patients less than 2 months of age.
Urinary Tract Infections and Shigellosis in adults and paediatric patients
and Acute otitis media in paediatric patients:
Adults : The usual adult dosage in the treatment of urinary tract infection
is one Health 2000 Co-trimoxazole DS Tablets 960 mg tablet or two HEALTH 2000
Co-trlmoxazoteTablets 480 mg tablets every 12 hours for 10-14 days. An identical
daily dosage is used for 5days in the treatment of shigellosis.
Paediatric patients : The recommended dose for paediatric patients with urinary
tract infections or acute otitis media is 8 mg/kg trimethoprim and 40 mg/kg
sulphamethoxazole per 24 hours, given in two divided doses every 12 hours
for 10 days. An identical daily dosage is used for 5 days in the treatment
of Shigellosis. The following table is a guideline for the attainment of this
dosage
Paediatric Patients : Two months of age or older.
Weight Dose Every 12 hours
LB kg Tablets.
22 10 —
44 20 1 Health 2000 Co-trimoxazole Tablets480 mg
66 30 1½ Health 2000 Co-trimoxazoleTablets 480 mg
86 40 2 Health 2000 Co-trimoxazoleTablets 480mg
(Or 1 Health 2000 Co-trimoxazole DS Tablets 960 mgtablet)
For patients with impaired renal function. When renal function is impaired a reduced dosage should be employed using the following table.
Creatinine clearance (ml/min) Recommended dosage regimen
Above 30 use standard Regimen
15-30 ½ the usual regimen
Below 15 use not recommended.
Acute exacerbations of chronic bronchitis in Adults:
One Health 2000 Co-trimoxazole DS Tablets 960 mg or two Health 2000 Co-trimoxazole
Tablets 480mg every 12 hours for 14 days.
Traveler’s Diarrhoea in Adults:
One Health 2000 Co-trimoxazole DS Tablets 960 mg tablets or two Health 2000
Co-trimoxazole Tablets 480mg tablets every 12 hours for
5 days.
Pneumocystis carinii pneurnonia
Treatment : Adults and paediatric patients 15-20 mg/kg trimethoprim and 75-100
mg/kg sulphamethoxazole per 24 hours given in equally divided doses every
6 hours fir 14-21 days.
The following table is a guideline for the upper limit of this dosage.
Weight Dose every 6 hours
LB kg Tablets
18 8 -
35 16 1 Health 2000 Co-trimoxazole Tablets 480mg
53 24 1½ Health 2000 Co-trimoxazole Tablets 480mg
70 32 2 Health 2000 Co-trimoxazole Tablets 480mg(or 1 Health 2000 Co-trimoxazole
DS Tablets 960 mg tablet)
88 40 2½ Health 2000 Co-trimoxazole Tablets 480mg
106 48 3 Health 2000 Co-trimoxazole Tablets 480mg (or 1½ Health 2000
Co-trimoxazole DSTablets 960mg tablet)
141 64 (or 2 Health 2000 Co-trimoxazole DS Tablets960mg tablets)
176 80 5 Health 2000 Co-trimoxazole Tablets 480mg (or 2½ Health 2000
Co-trimoxazole DSTablets 960mg tablets)
For the lower limit dose:
(15mg/kg trimethoprim and 75mg/kg sulphamethoxazole per 24 hrs)
administer 75% of the dose in the above table.
Prophylaxis
Adults : The recommended dosage for prophylaxis in adults in one HEALTH 2000
Co-trimoxazole DS Tabtets 960mg daily.
Paediatric patients: 150 mg/m2/day trimethoprim wlth 750 mg/m2/day sulphamethoxazole
given orally is equally divided doses twice a day on 3 consecutive days per
weak. The total daily dose should not exceed 320mg trimethoprim and 1600 mg
sulphamethoxazole. The following table is a guideline for the attainment of
this dosage in paediatric patients.
Body Surface Area Dose every 12 hours
(m2) Tablet
0.26 -
0.53 Health 2000 Co-trimoxazoleTablets 480mg
1.06 1 Health 2000 Co-trimoxazoleTablets 480mg
(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS
1. Urinary Tract Infections
2. Acute Exacerbations of chronic bronchitis in Adults
3. Acute otitis media in paediatrics
4. Traveler’s Diarrhoea in Adults
5. Shigellosis
6. Pneumocystis carinii Pneumonia
(iii) DESCRIPTION OF DOSAGE FORM
Health 2000 Cotrimoxazole tablets 480mg, a combination of trimethoprim and sulphamethoxazole (co-trimoxazole) exerts its bactericidal action by the sequential blockade of two bacterial enzyme systems in the biosynthesis of bacterial folic acid. The synergy thus produced, accounts for the high degree of bactericidal activity.
(iv) CONTRAINDICATIONS
Marked liver parenchymal damage, blood dyscrasias deficiency, known hypersensitivity
to sulphonamides and/or trimethoprim. Treatment must be discontinued on the
appearance of a skin rash, or if any element of the blood count is reduced.
Co-trimoxazole tablets is contraindicated in paediatric patients less than
2 months of age.
Warnings and Precautions
General: Co-trimoxazole Tablets should be given with caution to patients
with impaired renal or hepatic function, to those with possible folate deficiency
(e.g. the elderly, chronic alcoholics patients receiving anticonvulsant therapy,
patients with malabsorption syndrome and patients in malnutrition states)
and to those with severe allergy or bronchial asthma. In Glucose-6 phosphate
dehydrogenase deficient individuals, hemolysis may occur. This reaction is
frequently dose-related.
Use In the elderly : There may be an increased risk of severe adverse reactions
in elderly patients particularly when complicating conditions exist, e.g.
impaired kidney and I or liver or concomitant use of other drugs. Severe skin
reactions, or generalized bone marrow suppression or a specific decrease in
platelets are the most-frequently reported severe adverse reactions in elderly
patients. In those concurrently receiving certain diuretics, primarily thiazides,
an increased incidence of thrombocytopenia with purpura has been reported.
Appropriate dosage adjustments should be made for patients with impaired kidney
function.
Use in the treatment and prophylaxis for Pneumocystis carinii pneumonia in patients with Acquired Immunodeficiency Syndrome (AIDS)
The incidence of side-effects, particularly rash, fever, leukopenia and elevated aminotransferase (transaminase) values in AIDS patients who are being treated With Co-trimoxazole Tablets for Pneumocystis carinii pneumonia has been reported to be greatly increased compared with the incidence normally associated with the use of Co-trimoxazole Tablets in non-AlDS patients. The incidence of hyperkalemia and hyponatremia appeals to be increased in AIDS patients receiving Co-trimoxazole Tablets. Adverse effects are less severe in patients receiving Co- trimoxazole Tablets for prophylaxis. A history of mild intolerance to Co- trimoxazole Tablets in AIDS patients does not appear to predict intolerance of subsequent secondary prophylaxis. However if a patient develops skin rash or any sign of adverse reaction therapy With Cotrimoxazole Tablets should be re-evaluated.
DRUG INTERACTIONS
Cyclosporin: A decrease in the therapeutic effect of cyclosporin and an increased
risk of nephrotoxicity may occur on co-administration of co-trimoxazole.
Methotrexate: The bone marrow depressant effects of methotrexate may be potentiated
by sulphamethoxazole
Phenytoin: Hepatic clearance of phenytoin may be decreased and half life increased.
Diuretics: An increased incidence of thrombocytopenia with purpura has been
observed in elderly patients concurrently receiving certain diuretics, primarily
thiazides.
Hypoglycaemics: Care should be taken when giving Health 2000 Cotrimoxazole tablets 480mg to patients receiving strongly serum proteinbound drugs such as oral hypoglycaemic agents or coumarin anticoagulants as the action of these drugs may be increased. Health 2000 Cotrimoxazole tablets 480mg may prolong the prothrombin time in patients receiving the anticoagulant, warfarin. This interaction should be borne in mind when Health 2000 Cotrimoxazole tablets 480mg is given to patients already on anticoagulant therapy. In such cases, the coagulation time should be re-determined.
PREGNANCY
Health 2000 Cotrimoxazole tablets 480mg is not recommended for use in pregnant
women.
NURSING MOTHERS
Health 2000 Cotrimoxazole tablets 480mg is not recommended for use by nursing
mothers, because both drugs are secreted in breast milk.
PAEDIATRIC USE
Health 2000 Cotrimoxazole tablets 480mg is contraindicated in paediatric patients
less than 2monts of age.
IN THE ELDERLY
There is an increased risk of severe adverse reactions in the elderly and
in patients with bronchial asthma.
IN IMPAIRED RENAL FUNCTION
See Dosage and Administration.
IN IMPAIRED HEPATIC FUNCTION
The drug should be given with caution in these patients.
DURATION OF THERAPY
The indiscriminate use of Health 2000 cotrimoxazole tablets 480mg for common
conditions can lead to serious blood disorders.
Long-term therapy particularly in elderly patients for prolonged periods (exceeding
three months), requires regular monthly blood counts since it has been suggested
that the elderly are more susceptible to blood dyscrasias.
OTHERS
Adequate fluid intake should be ensured to maintain an adequate urinary output
in order to prevent crystalluria and stone formation.
(v) SIDE EFFECTS
The most common side effects are gastrointestinal disturbances and allergic skin reactions. Hypersensitivity reactions have occasionally been reported.
Overdosage
Symptoms and signs of overdosage may include nausea, vomiting, mental and
visual disturbances, pyrexia, petechiae, purpura, jaundice, anorexia, colic,
bone marrow depression and abdominal pain. Blood dyscrasias are potential
late manifestations. Haematuria, crystalluria and anuria may occur in severe
cases.
Treatment is symptomatic and may include gastric lavage and forced diuresis.
Alkalinisation of the urine may aid the elimination of the sulphamethoxazole
component but may decrease the elimination of the trimethoprim component.
Hypersensitivity reactions may require treatment with steroids. Calcium folinate,
3 to 6 mg intramasculary for five to seven days, may be given to counteract
the effects of trimethoprim on haemopoiesis
(vi) TOXIC EFFECTS
Mutagenicity, Carcinogenicity and Teratogenicity
Considerable experience of safety is observed in first trimester. Cotrimoxazole
is Kernicterus to fetus. There are no known human data on long-term potential
for carinogenicity, mutagenicity, or impairment of fertility. A few cases
of accelerated growth of lung carcinoma have been reported in man, but a causal
relationship with the drug has not been established. No evidence of carcinogenicity
was found in male mice of the same strain, mice of a different strain, or
rats under similar experimental conditions